Medicines For Europe’s Leader Marks A Decade Of Change

Towards the end of 2013, Adrian van den Hoven took over as director general of what was then the European Generic and Biosimilar medicines Association (EGA). Now, a decade on, he is still at the helm of the organization now known as Medicines for Europe.

In an exclusive in-depth three-part interview with Generics Bulletin, he discusses the changes seen in the European off-patent industry over the last ten years, the way Medicines for Europe has evolved as an organization, and the opportunities on the horizon for generics, biosimilars and off-patent medicines.

Asked first how he would summarize the changes seen for the European off-patent industry since 2013, van den Hoven said “I think a lot of things have changed. The industry has a much bigger footprint.”

“I know that already, when I came in, I think we already had 60% of the market or something like that in volume terms. So we already had a huge footprint. And then biosimilars really took off – they already existed, of course, but they really took off with the monoclonal antibody antibodies and things like that. And now we’re around 70% of the volume of the market – so that public health role has really expanded.”

Broadening The Organization’s Scope

Another aspect that had significantly expanded, he explained, was the scope of Medicines for Europe and its member companies in terms the aspects of European healthcare that they could involve themselves in.

“The companies understood that within Medicines for Europe, it’s about: okay, how does the industrial and commercial model fit with the public health role that we play, which is to supply almost all of the essential and critical medicines, to expand access and sustain the healthcare systems.”

This was “really a mindset shift,” he elaborated, “because there was a lot of scepticism at the beginning” about expanding the scope of the organization beyond direct business aspects. “And that has really, really changed fundamentally. The members have integrated this very much into their thought and engaged kind of automatically around these types of issues.”

“We spoke to specialized physicians who – many of them – told us from the outset: we don’t trust biosimilars and we never will. That’s a good start to a conversation!”

Initially, van den Hoven acknowledged, there was a degree of scepticism about engaging with patient associations, which some companies thought were “on the originator side.”

“I said, well, we need to talk to them first to see if they’re on the originator side, or if they might also be interested in some generic or biosimilar issues. Maybe they will. And sure enough, they were very interested in these topics.”

“It was a new conversation, it took some time…the same with medical doctors, and things like that.” But “the world opened up, I would say, over the years, and it has been super exciting. So it was a big mindset change.”

Sometimes, van den Hoven acknowledged, “we didn’t like their voices – you know, we didn’t like the stakeholders to criticize generics or biosimilars. But then the good thing was that we then had to give a response – and say well, if you don’t trust biosimilars, then we have to explain why you should trust biosimilars. Let’s give this a try.”

“That’s what truly broke open the biosimilars market,” he suggested. “The fact that we spoke to specialized physicians who – many of them – told us from the outset: we don’t trust biosimilars and we never will. That’s a good start to a conversation! But we said, well, let’s talk about it. And that really worked.”

A New Vision – And A New Name

Asked whether the name change from the EGA to Medicines for Europe came out of this messaging and sense of responsibility around public health, van den Hoven said “absolutely – it kind of flowed,” with the new name also growing out of a fresh vision for the industry association.

“When I became the director, I got a new president, which was Nick Haggar,” he recalled. “He was at Sandoz at the time. And it was actually him who said, Adrian, we can’t work without a vision. He said, let’s make a vision.”

After drawing up a vision for the association, van den Hoven conceded that “it took a while to get our own members to buy into the vision. But then members started to buy into it – to say, hey, this vision is working. This vision makes a lot of sense. It’s actually what we do. It represents us pretty well. So after that initial scepticism, the members really bought into it. And then we were taking it forward.”

At the same time, within the association the wider remit of biosimilars as well as generics was also being considered. “And then we were starting to work on value added medicines at the time – we didn’t have the name – and they said, well, that’s not really a generic is it? You know, why are we calling everything generic? So then we said, okay, let’s change the name.”

“But it really started with the vision. And then the fact that we were doing more than generics – including generics, super important, but more than that – and then in the process we ended up with Medicines for Europe. And Medicines for Europe is linked to this vision that we’re supplying public health.”

A More Collaborative Approach To The Originator Industry

Asked whether his tenure also marked a shift in the way the off-patent industry engaged with the originator sector – moving towards a more open, collaborative approach over an adversarial relationship – van den Hoven said “definitely.”

While Medicines for Europe made outreach efforts “to all stakeholders: like patient groups, doctors, groups, consumer groups – we really stepped up that aspect,” a key aspect was “cooperation with EFPIA and the other pharma associations.” And “EFPIA is obviously the most important one.”

“And I think what has been lucky is actually, you know, the head of EFPIA and myself, we’ve always gotten along pretty well,” he indicated. “So there was Richard Bergström. And now there’s Nathalie Moll. I knew both of them – not super well, but I knew both of them from before. And it’s been rather easy to get along.”

“Of course, we’ve had some major disagreements,” van den Hoven acknowledged, “usually on issues related to intellectual property. And biosimilars, at the beginning.” But he said the two sides of the industry had “managed to have very intense fights over those issues, but not disrupt the entire relationship.”

“So while we were throwing eggs at each other over those kinds of topics, we were cooperating with each other on regulatory issues, or shortages, or different kinds of themes like that.”

“We even made joint efforts in Central and Eastern Europe to try and solve some of the complex problems there. I don’t think we did, but we tried. And all the while fighting on some other topics where, you know, we just have different views. So that’s worked out pretty well.”

Significant Change Within Medicines For Europe

Moving on to discuss how Medicines for Europe had itself changed as an organization over the past decade, van den Hoven said “I think it changed a lot.”

“Certainly, we’ve grown bigger, in terms of the number of companies and the number of staff,” he observed. “Also, we’ve really grown in what we do, as well. When we started, we basically worked on markets, regulatory, and legal, those were the things. Now we work on communications and public affairs. We have whole departments doing that. Small departments, but they’re still departments we have.”

Another key issue on which the association had engaged in more depth over the past ten years was “manufacturing and supply chain – which we actually started working on before the COVID pandemic,” van den Hoven pointed out.

“We said, okay, we’re going to start working on manufacturing and supply chain issues. Because we knew that we were going to face these issues with supply chains and shortages and things like that, because of the way the markets are organized.”

“So we said, let’s get ahead of it and start working on this – and then before we could set up that committee, the COVID pandemic hit. And that was mainly us working on supply chain problems during COVID. And so then we said, well, I guess we’re not going to stop here. We’re going to continue and have a whole committee devoted to manufacturing and supply chain.”

More recently, the association had put a particular emphasis on “promoting investments, or trying to encourage investment in manufacturing in Europe – which, as you know, is difficult. I mean, India and China are very attractive places to invest for manufacturing. But what are the competitive advantages that Europe offers? We try and of course, find some, or create some.”

In the second part of this interview, van den Hoven discusses the rise in prominence of biosimilars in Europe, the way the off-patent industry has dealt with crises such as the COVID-19 pandemic or the war in Ukraine, as well as achievements such as the SPC manufacturing waiver. (Also see "Triumphs And Crises: European Industry Chief Reflects On The Past Ten Years" - Generics Bulletin, 2 Jan, 2024.)